Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Miniplates
Primary Purpose
Mandible Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fixation of angle fracture
Sponsored by
About this trial
This is an interventional treatment trial for Mandible Fracture focused on measuring angle fracture
Eligibility Criteria
Inclusion Criteria:
- Patients with unilateral angle fracture.
- Patients free from any systemic disease & bone metabolism diseases.
- No sex predilection
- Age range ( 15-70)
Exclusion Criteria:
- Comminuted fragmented & infected angle fractures.
- Bilateral angle fracture.
- Systemic diseases.
- bone metabolism diseases
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
K plate
Conventional two miniplates
Arm Description
fixation of angle fracture using K plate versus two miniplates
fixation of angle fracture using K plate versus two miniplates
Outcomes
Primary Outcome Measures
Stability of angle fracture fixation
Inter-ramus distance (fixed position at the lingual), inter-mental distance will be obtained from the immediate postoperative facial bone CT & after 3 months. Comparison between the 2 records will be done to assess the stability of fixation technique.
Bone density will be measured by Hounsfield unit at fracture site immediate postoperative & after 3 months using F.B.CT.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03839368
Brief Title
Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Miniplates
Official Title
Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Conventional Miniplates: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
April 11, 2020 (Anticipated)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In patients with angle fracture , will the (K) shaped titanium miniplates provide more stable fixation than two conventional miniplates? Many studies have been conducted to compare between different techniques of fixation used in angle fracture fixation. The driving force behind this study was to design a new plate that would overcome the disadvantages of the other plating techniques but has the advantages & simplicity of the Champy technique (simple intraoral approach and few major complications). This new miniplate gives more biomechanical stability than the conventional Champy plate. More over the placement of a 3D miniplate or two separate miniplates for fixing angle fractures is more difficult and mostly will require a transbuccal approach , with increased surgical trauma, longer operation time unlike the new plate that could provide the clinician with a simple and reliable solution.
Detailed Description
In the past two decades, rigid internal fixation with miniplate has become the standard treatment modality in the management of mandibular fracture.
The optimal management of mandibular angle fractures remains controversial, thus continuous experimental & clinical studies are being conducted to determine the best miniplate design which will provide the best postoperative stability & resistance to mechanical function.
Since Michelet et al.& Champy et al. recommended the use of a single (4-6 holes) monocortical plate , it become an acceptable method for angle fractures fixation.
Several surgeons have documented low complication rates with (Champy technique).But, according to the most recent experimental & clinical studies, the stability provided by the miniplate fixation has become a point of debate among surgeons.Many researchers have argued that internal fixation with a passive miniplate along the external oblique line, following Champy's ideal osteosynthesis line principle, produces a tension effect that may yield a failure of osteosynthesis & gap at inferior border of the mandible.And that pushed researches to conduct more studies to evaluate many plate & screw systems and even suggest new designs for better stable postoperative results.
In 2014, B.T.Suer et al, designed a new noncompression 3D miniplates , basically it has one straight section and two lateral extensions. The straight section of this new design, which has four holes, was adapted to the superior border of the external oblique ridge & provides similar advantages to the Champy technique (an intraoral approach, a single miniplate, & the use of monocortical screws) .And the two lateral extensions, with one hole each, were then bent over to adapt to the buccal cortex of the ascending ramus along the external oblique ridge to resist lateral & torsional forces.
Fresh, frozen cadavers of 15 healthy sheep were obtained for this study, sheep were used in this study owing to the similarities in size & thickness to the human mandible. All of the mandibles were stripped of their soft tissues & sectioned through the midline, between the central incisors. 30 hemimandibles were randomly divided into two groups , these groups were then fixed with two different plating techniques (the new design & one conventional miniplates). And they were all examined for stability and resistance to mechanical forces (vertical, lateral, or tensile).
The driving force behind this study was to design a new plate that would overcome the disadvantages of the other plating techniques but has the advantages & simplicity of the Champy technique (simple intraoral approach and few major complications). This new miniplate gives more biomechanical stability than the conventional Champy plate. These findings are correlated to those of in vitro biomechanical study done by Alkan et al. that showed that Champy technique has less favourable biomechanical behaviour than biplanar fixation and 3D strut plate. In addition the new plate provide greater stability when subjected to lateral displacing forces.
More over the placement of a 3D miniplate or two separate miniplates for fixing angle fractures is more difficult and mostly will require a transbuccal approach , with increased surgical trauma, longer operation time unlike the new plate that could provide the clinician with a simple and reliable solution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandible Fracture
Keywords
angle fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
Participant
Masking Description
Cards will have sequential numbers one number for each card then these cards will be placed within opaque sealed envelopes. Then these envelops will be placed in a container (box), each participant will grasp one envelope the day of procedure.
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
K plate
Arm Type
Experimental
Arm Description
fixation of angle fracture using K plate versus two miniplates
Arm Title
Conventional two miniplates
Arm Type
Active Comparator
Arm Description
fixation of angle fracture using K plate versus two miniplates
Intervention Type
Procedure
Intervention Name(s)
fixation of angle fracture
Intervention Description
open reduction and internal fixation of angle fracture
Primary Outcome Measure Information:
Title
Stability of angle fracture fixation
Description
Inter-ramus distance (fixed position at the lingual), inter-mental distance will be obtained from the immediate postoperative facial bone CT & after 3 months. Comparison between the 2 records will be done to assess the stability of fixation technique.
Bone density will be measured by Hounsfield unit at fracture site immediate postoperative & after 3 months using F.B.CT.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with unilateral angle fracture.
Patients free from any systemic disease & bone metabolism diseases.
No sex predilection
Age range ( 15-70)
Exclusion Criteria:
Comminuted fragmented & infected angle fractures.
Bilateral angle fracture.
Systemic diseases.
bone metabolism diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hagar A Mohamed, BDS
Phone
01016799911
Email
hagar_elsherif92@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagar Mohamed, BDS
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24582290
Citation
Suer BT, Kocyigit ID, Kaman S, Tuz HH, Tekin U, Atil F. Biomechanical evaluation of a new design titanium miniplate for the treatment of mandibular angle fractures. Int J Oral Maxillofac Surg. 2014 Jul;43(7):841-5. doi: 10.1016/j.ijom.2014.01.011. Epub 2014 Feb 24.
Results Reference
background
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Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Miniplates
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